Equipment and QMS Software by Verification Process

OVERVIEW:
The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world".

Product Id : 501161

Instructor : John E Lincoln

Wednesday, March 8, 2017   |   10:00 AM PST | 01:00 PM EST   |   Duration: 90 Minutes

WHY SHOULD YOU ATTEND: 
Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. A quick review of Internet forums will show much confusion about the subject.

AREAS COVERED IN THE SESSION:

• Verification or Validation-FDA Expectations
• The Project V&V Plan
• An FDA-accepted Documentation "Model"
• Product and Process/Test Facilities/Equipment Software V&V
• When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
• The FDA's 11 Key V&V Documentation Elements
• "White Box" and "Black Box" Validations
• IEC 62304,GAMP/Other Considerations

WHO WILL BENEFIT:

• Senior management in Drugs,Devices,Combination Products,Biologics,Dietary Supplements
• QA / RA
• Software development,Programming,Documentation,Testing teams
• R&D
• Engineering
• Production
• Operations
• Consultants,Others tasked with product,Process,Electronic records software V&V responsibilities

SPEAKER PROFILE:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.

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